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The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis

NCT02965898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-04-16

No results posted yet for this study

Summary

Acute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency.

Recently, the investigators and others have found that vitamin D may protect from the formation of fibrosis on cellular level. The investigators hypothesized that after the first AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and designed this RCT.

The aim is to study whether the investigators can prevent CP with vitamin D substitute.

In this randomized controlled patient study, the patients after their first AP are randomized to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin D substitute daily. The patients are examined by MRI/MRCP imaging and laboratory tests at the baseline after recovery from AP and yearly then after.

Primary endpoint is the development of parenchymal changes possibly related to fibrosis. Secondary endpoints are the development of CP with Mannheim criteria, CP related complications and mortality.

The first analysis will be done after 7 years.

The enrollment will begin 26.9.2016

Conditions

  • Chronic Pancreatitis

Interventions

DIETARY_SUPPLEMENT

Vitamin D 100ug

Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.

DIETARY_SUPPLEMENT

Vitamin D 10ug

Placebo dose. Minimal recommended dose.

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    collaborator INDUSTRY

  • Tampere University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
101 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2024-03-10
Completion
2024-03-10

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965898 on ClinicalTrials.gov